About this opportunity
Redbock - an NES Fircroft company lists this Design Quality Engineer opportunity in marlborough, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Work Arrangement: Hybrid – preferred onsite 3 days per week
Expected Duration: Early November 2026 through December 2027
Position Overview
We are seeking a Design Quality Engineer to support Design History File (DHF) remediation and Design Controls initiatives within a regulated medical device environment. This individual will partner with Quality, R&D, Regulatory Affairs, and other cross-functional stakeholders to assess, remediate, and strengthen design control documentation across legacy and active product portfolios.
The ideal candidate is a self-driven quality professional with strong technical writing skills, sound judgment, and a hands‑on approach to resolving documentation gaps. This role requires the ability to navigate incomplete information, independently identify compliance gaps, develop practical solutions, and drive remediation activities through completion while maintaining a high standard of quality and regulatory compliance.
Key Responsibilities
Review and assess existing Design History Files (DHFs) to identify documentation gaps, inconsistencies, and compliance risks.
Develop and execute remediation strategies for design inputs, design outputs, design verification, design validation, design reviews, risk management, and traceability documentation.
Author, revise, and review design control documentation and quality records to ensure completeness, accuracy, consistency, and audit readiness.
Partner with cross-functional teams to reconstruct product development history and establish objective evidence supporting design decisions.
Develop and maintain requirements traceability matrices and supporting design control documentation packages.
Support risk management activities, including design FMEAs, hazard analyses, and risk/benefit assessments.
Interpret and apply FDA, ISO 13485, ISO 14971, and internal quality system requirements within remediation activities.
Collaborate with global stakeholders to align on remediation strategies, resolve documentation challenges, and drive deliverables to closure.
Support internal audits, inspections, and remediation effectiveness reviews as required.
Identify opportunities to improve remediation processes, tools, and methodologies, increasing efficiency while maintaining compliance.
Required Qualifications
Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Quality Engineering, or a related technical discipline.
3–5 years of experience in the medical device industry or another regulated environment.
Working knowledge of design controls, risk management, and product development processes.
Hands‑on experience with risk management documentation, including DFMEAs and hazard analyses.
Familiarity with FDA quality system requirements, ISO 13485, ISO 14971, and applicable medical device regulations.
Strong technical writing skills and the ability to develop clear, accurate, and compliant documentation.
Demonstrated ability to independently manage multiple priorities and deliver high-quality work with minimal supervision.
Strong analytical, organizational, critical‑thinking, and problem‑solving skills.
Effective communication and collaboration skills when working with cross‑functional and global teams.
Preferred Qualifications
Direct experience with DHF remediation, Design Assurance, Design Quality Engineering, or design control compliance initiatives.
Experience supporting remediation programs, regulatory commitments, audit findings, or CAPA‑related activities.
Knowledge of traceability methodologies and requirements management.
Experience supporting Class II or Class III medical device product development, preferably within Endoscopy.
Working knowledge of design control requirements under 21 CFR Part 820 and ISO 13485.
#J-18808-Ljbffr
Worksite address
marlborough, MA, 01752, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.